OTCQB-CSDX Appoints Lachman Consultants for CS-Protect Hydrogel FDA Approval

Rhea-AI Summary

CS Diagnostics Corp. (OTCQB:CSDX) has appointed Lachman Consultants to support FDA approval for its CS-Protect Hydrogel, an innovative organ spacer medical device for cancer radiology treatments. The company expects FDA approval within 3-4 months.

CS-Protect Hydrogel is a ready-to-use product that offers enhanced versatility compared to previous products, featuring advanced molecular structure and chemical physical properties. The product requires no preparation steps after removal from sterile packaging, eliminating contamination risks.

The company projects production start in the U.S. market by Q1 2026. Management notes that a predecessor product in this space was acquired by Boston Scientific for $500 million, highlighting the potential market value of such technology.

Positive

• Ready-to-use product design eliminates contamination risks
• Enhanced versatility compared to previous products
• Similar predecessor product sold for $500M to Boston Scientific
• Expected short FDA approval timeline of 3-4 months

Negative

• Production won't start until Q1 2026, indicating significant time to market
• FDA approval still pending and subject to regulatory risks

CS DIAGNOSTICS CORP. ANNOUNCES THE APPOINTMENT OF FDA CONSULTANTS

Innovative tissue spacer technology for cancer radiology treatments

CHEYENNE, WYOMING / ACCESS Newswire / March 12, 2025 / CS Diagnostics Corp. (OTCQB:CSDX) (or "the company") is delighted to announce the appointment of Lachman Consultants Inc., Westbury, NY www.lachmanconsultants.com to provide its regulatory expertise and support in the company's effort to acquire FDA approval for its CS-Protect Hydrogel.

CS-Protect Hydrogel is an organ spacer medical device that requires registration or approval from the respective governmental authorities, in particular the Food and Drug Administration (FDA) in the USA. Unlike the previous products, CS-Protect Hydrogelis more versatile and can also be used in other pathologies. CS-Protect Hydrogelis an advanced technology from molecular structure, chemical physical properties and medical applications. Registration was preceded by a testing procedure. CS Diagnostics Corp. anticipates a period of 3 to 4 months for approval in the U.S. Market.

Since 1978, Lachman Consultants have furnished expert compliance, regulatory affairs and technical services to clients around the world helping avoid and resolve compliance problems, assisting in the development of efficient and effective strategies for the submission, and approval of drugs and devices. Lachman Consultants serves all areas of global regulatory compliance-related activities for the Pharmaceutical, Biotechnology, Biologics, CGT, Device and Allied Health Industries.

Thomas Fahrhoefer, President of the Board at CS Diagnostics Corp., added:

" The Easy application of the CS-Protect Hydrogel being a ready-to-use product after removal from sterile packaging and unrequired further work steps eliminates any risk of contamination due to preparation and assembly of the product exclusion of another hygienic risk area within the treatment room. Also, no risk of wrong mixture especially wrong sequence and therefore no potential patient's missed treatments. "

Mohammad EsSayed, Vice President of the Board at CS Diagnostics Corp., commented:

" The predecessor product was acquired by Boston Scientific for $ 500 million (https://news.bostonscientific.com/2018-10-16-Boston-Scientific-Closes-Acquisition-of-Augmenix-Inc). We project the start of the production of CS-Protect Hydrogel in the U.S. market towards the first quarter of 2026."

Looking toward the future, CS Diagnostics Corp. is positioning itself for long-term growth with breakthrough innovations. As a listed entity on OTCQB, CS Diagnostics Corp. provides U.S. investors with access to a high-growth opportunity, ensuring long-term shareholder value by creating and executing impactful, market-leading solutions.

Forward-Looking Statements

This announcement contains forward-looking statements relating to expected or anticipated future events and anticipated results that are forward-looking in nature and, as a result, are subject to certain risks and uncertainties, such as general economic, market and business conditions, competition for qualified staff, the regulatory process and actions, technical issues, new legislation, uncertainties resulting from potential delays or changes in plans, uncertainties resulting from working in a new political jurisdiction, uncertainties regarding the results of exploration, uncertainties regarding the timing and granting of prospecting rights, uncertainties regarding the timing and granting of regulatory and other third party consents and approvals, uncertainties regarding the Company's or any third party's ability to execute and implement future plans, and the occurrence of unexpected events.

Actual results achieved may vary from the information provided herein because of numerous known and unknown risks, uncertainties, and other factors.

For further information please visit https://csdcorp.us/cs-protect-hydrogel/

or contact

Mohammad Essayed
Email: mohammad.essayed@csdcorp.us

SOURCE: CS Diagnostics Corp.

View the original press release on ACCESS Newswire

FAQ

When is CS Diagnostics (CSDX) expecting FDA approval for CS-Protect Hydrogel?

CSDX anticipates FDA approval within 3-4 months from March 12, 2025.

What are the key advantages of CSDX's CS-Protect Hydrogel over previous products?

CS-Protect Hydrogel is more versatile, ready-to-use, requires no preparation steps, and eliminates contamination risks during application.

When will CSDX begin production of CS-Protect Hydrogel in the US market?

Production is projected to start in the first quarter of 2026.

What was the acquisition value of the predecessor product to CSDX's CS-Protect Hydrogel?

The predecessor product was acquired by Boston Scientific for $500 million.